Apparatus and method for improved assisted ventilation

ABSTRACT

Devices and methods for allowing for improved assisted ventilation of a patient. The methods and devices provide a number of benefits over conventional approaches for assisted ventilation. For example, the methods and devices described herein permit blind insertion of a device that can allow ventilation regardless of whether the device is positioned within a trachea or an esophagus. In addition, the methods and device allow for timed delivery of ventilations based on a condition of a thoracic cavity to increase the amount and efficiency of blood flow during a resuscitation procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present is a continuation of U.S. patent application Ser. No.15/798,146 filed Oct. 30, 2017, which is a continuation of U.S. patentapplication Ser. No. 14/750,998 filed Jun. 25, 2015 (now U.S. Pat. No.9,802,014 issued on Oct. 31, 2017), which is a continuation of U.S.patent application Ser. No. 14/666,244 filed Mar. 23, 2015 (now U.S.Pat. No. 9,757,530 issued on Sep. 12, 2017), which claims the benefit toU.S. Provisional Application 61/969,043 filed Mar. 21, 2014 and is acontinuation-in-part of U.S. patent application Ser. No. 14/296,298filed Jun. 4, 2014 (now U.S. Pat. No. 9,220,858 issued on Dec. 29,2015), which is a continuation of U.S. patent application Ser. No.13/659,699 filed Oct. 24, 2012 (now U.S. Pat. No. 8,776,796 issued onJul. 15, 2014) which claims the benefit to U.S. Provisional ApplicationNo. 61/569,169 filed Dec. 9, 2011, the content of each of which isincorporated herein by reference in its entirety. The presentapplication also incorporates PCT Application No. PCT/US2015/022079filed Mar. 23, 2015 in its entirety by reference herein.

BACKGROUND OF THE INVENTION

Intubation is the placement of a tube of an intubation device into anairway lumen of the body of a patient to provide assisted ventilation ofthe lungs to maintain a supply of oxygen to the blood in those caseswhere the patient is unable to breathe on his or her own. Intubation incases of respiratory distress involves the placement of a tube into thetrachea of the patient. Tracheal intubation also involves thepositioning of an endotracheal tube into a patient's trachea through thevocal cords, so the caregiver must also be careful to avoid injuring thevocal cords. In many cases, care must be taken when intubating a patientsince improper placement of the tube can result in additional harm tothe patient. For example, many conventional intubation devices rely onan inflatable cuff that forms a seal against the lumen wall to maintaina position of the tube within the lumen. Over-inflation of the cuff, cancause internal bleeding in the patient. Another significant problem isthat extreme care must be taken to avoid positioning the intubation tubewithin the esophagus rather than the trachea. In such cases, withconventional devices, the first responder or medical practitioner cannotproperly ventilate the patient and the patient can suffer furtherinjury.

Even properly trained medical caregivers and first responders mustproceed with caution during intubation to avoid misplacement of theintubation device or to avoid unwanted insertion errors and risk ofinjury. Delay and/or misplacement of the endotracheal tube, such asmisplacement of the endotracheal tube into the esophagus, canpotentially result in neurological damage or death. Improper positioningof the endotracheal tube also can compromise airway protection or resultin inadequate ventilation. It is therefore imperative to intubate apatient quickly and position the endotracheal tube correctly when amedical condition arises.

To reduce the risk of complications during intubation, the caregiver,whether a first responder, such as an emergency medical technician,paramedic, or a nurse or physician must proceed as quickly as possibleyet with caution to avoid the potential complications. In addition, afirst responder must often attempt to intubate the patient in a lessthan desirable location such as a bathroom, restaurant, or other areanot conducive to providing proper medical treatment and care.

Assisted ventilation in cases of cardiac arrest also requires prompt andaccurate placement of an intubation device within the trachea so thatchest compressions can occur. In such cases, intubation allows forventilation of the lungs and a supply of oxygen to the blood while chestcompressions provide circulation of the blood.

The American Heart Association's protocols for cardio pulmonaryresuscitation (CPR) previously required pausing after every fifteenchest compressions to allow for two ventilations. The American HeartAssociation's 2010 protocols decreased the frequency of ventilationssuch that chest compressions are to be paused after every thirtycompressions to allow for two ventilations. It is believed that the mainreasons supporting the change in protocol are: 1) reduce the amount ofintra-thoracic pressure associated with positive pressure ventilationssince positive pressure ventilations decrease the efficiency of theheart; and 2) to minimize the interruptions of chest compressions tomaintain constant arterial pressure. Accordingly, now most caregiversonly simultaneously ventilate the patient and provide compressions ifthe patient is properly intubated.

FIG. 1 provides a partial view of a patient's oral cavity 10, tongue 12and pharynx 14 where the pharynx 14 is the membrane-lined cavity at therear of the oral cavity 10. The pharynx 14 includes openings of theesophagus 16 and trachea 18. As shown, the openings to the esophagus 16and trachea 18 are adjacent to one another. When a medical caregiverattempts to intubate a patient, the caregiver shall attempt to positionthe intubation device within the trachea 18 to provide oxygen to thelungs 2. As noted above, the caregiver shall attempt to avoidpositioning the intubation device within the esophagus 16 and in doingso often must proceed slowly and with caution to avoid causing undesiredtrauma to vocal cords or other structures within the body.

The wall of the esophagus 16 is composed of striated and smooth muscle.Since the esophagus 16 relies on peristalsis to move food downwardtowards the stomach, the walls of the esophagus 16 are naturallycompliant and do not have any structural reinforcement. The trachea 18,on the other hand, is relatively stronger and is naturally designed notto collapse given its function of transporting air to the bronchi andlungs 2. The wall of the trachea 18 includes a number of cartilaginoussemicircular rings 20 that prevent the trachea 18 from collapsing. Thetrachea 20 lies anteriorly to the esophagus 16 where the openings of theesophagus 16 and trachea are separated by a tiny flap, the epiglottis22. The epiglottis 22 protects the trachea when the individual swallowsfood or other substances.

FIG. 2 illustrates a conventional device 50 used for intubating apatient. As shown, the device 50 is inserted through the mouth and oralcavity into the trachea 18. The caregiver must navigate the device 50into the trachea 18 rather than the esophagus while traversing theepiglottis 22 and vocal cords 24. The caregiver must take particularcare to avoid causing damage to the vocal cords 24. Once properlypositioned, the caregiver can optionally inflate 52 a balloon on thedevice 50 to anchor the device within the trachea 18. After thecaregiver confirms placement of the device 50, ventilation of thepatient can take place.

Presently, the Combitube, supplied by Nellcor, is commonly used forairway management. The Combitube, also known as a double-lumen airway,is a blind insertion airway device (BIAD) used by first responders aswell as in an emergency room setting. The Combitube is intended to allowfor tracheal intubation of a patient in respiratory distress by use of acuffed, double-lumen tube. The double lumen tube is inserted into thepatient's airway to allow for ventilation of the patient's lungs.Inflation of the cuff allows the device to function similarly to anendotracheal tube and usually closes off the esophagus, allowingventilation and preventing pulmonary aspiration of gastric contents.

However, placement of traditional intubation devices is very difficultdue to the risk of improperly positioning the device. The risk of adevice being improperly positioned can be fatal if not recognized. Theconventional devices described above require positioning by anindividual that is well trained in positioning such devices.Furthermore, even well trained individuals must proceed with cautionwhen placing conventional devices.

In addition, there remains a need to improve timing of air deliveryduring artificial ventilations of a patient. This need especiallyremains where the patient is experiencing distress and requires bothventilation for oxygen and chest compression to re-establish bloodcirculation. Presently, if the act of artificially ventilating theindividual (e.g., through assisted ventilation or mouth-to-mouth) andproviding chest compressions is not timed, such as during normal CPR,normal artificial ventilation of the individual can work against theeffectiveness of the compression. For instance, assisted ventilation byrepeatedly delivering a large bolus of air can raise the pressure withinthe thoracic cavity and increase resistance by raising pressure on theheart. This back pressure can prevent the heart and lungs from fillingwith blood. As a result, impeding the ability of the heart and lungs tofill with blood, makes the chest compression less effective as a lowervolume of blood is circulated after the compression.

There remains a need for a ventilation device and/or system that caneffectively ventilate individuals and can be effectively positioned withminimal training required by the caregiver. In addition, there remains aneed for such ventilation devices and methods to optimize the effect ofproviding assisted ventilation with chest compressions to circulateoxygenated blood within an individual.

SUMMARY OF THE INVENTION

The present disclosure includes devices and method allowing for improvedassisted ventilation of a patient. The methods and devices provide anumber of benefits over conventional approaches for assistedventilation. For example, the methods and devices described hereinpermit blind insertion of a device that can allow ventilation regardlessof whether the device is positioned within a trachea or an esophagus.Some variations of the devices and methods allow minimally trainedbystanders and laypersons to place an advanced airway for assistedventilation. The devices described herein can be designed such that asingle size can accommodate a variety of patient sizes thereby reducingthe number of devices of varying sizes that must be kept in inventory.Additionally, having devices that can accommodate a wide range ofindividuals reduces the need of a first responder to assess the anatomicfeatures of a patient prior to acting on the patient. In patientsundergoing cardiac distress, delivery of large boluses of air during CPRcan result in hyperventilating the patient, which can decrease theeffectiveness of CPR. Elevated intrathoracic pressure can ultimatelyreduce the effectiveness of chest compressions. Variations of thecurrent device and methods allow for controlled ventilation, whichavoids hyperventilation.

In another variation, the devices described in the present disclosureallow for improved assisted ventilating an individual. For example, avariation of the method includes inserting a ventilation device into theindividual by advancing a working end of the ventilation device within abody passage of the individual, where the working end includes a faropening fluidly coupled to a first lumen and a medial opening fluidlycoupled to a second lumen; drawing suction through the opening andattempting to hold a vacuum through the first lumen and the far openingfor a pre-determined period of time; automatically ventilating theindividual through the second lumen upon detecting the vacuum during thepre-determined period of time and maintaining suction to maintain thevacuum; and automatically ventilating the individual through the firstlumen upon failure to detect the vacuum during the pre-determined periodof time; where automatically ventilating the individual occurs at apre-determined timing; measuring a condition of a thoracic cavity todetermine a change in the thoracic cavity; and altering a timing ofautomatically ventilating of the individual upon detecting the change inthe condition of the thoracic cavity.

The present disclosure also includes a system artificially ventilatingan individual, the system comprising: a ventilation device configuredfor insertion within a respiratory opening of the individual and havinga working end for positioning within a body passageway of theindividual, the ventilation device having a pressure sensor configuredto detect pressure changes within the body passage; and the ventilationdevice having a control system configured to deliver a bolus of air intoan airway the individual at a pre-determined rate until detection of thepressure change within the body passageway, whereafter the controlsystem is configured to alter the pre-determined rate by delayingdelivery of the bolus of air until the sensor detects the pressurechange in the air within the body passage, where the pressure changewithin the body passage results from a chest compression.

Measuring the condition of the thoracic cavity can include measuring thecondition of the thoracic cavity using the ventilation device ormeasuring a change in a compression of a chest of the patient. Forexample, measuring the change of the compression of the chest of thepatient comprises observing a force applied to the ventilation device bythe body passageway. Alternatively, measuring the change of thecompression of the chest of the patient comprises observing a deflectionof the chest of the patient using one or more sensors on the chest.

In an additional variation, measuring the condition of the thoraciccavity comprises measuring a state of air flow within the thoraciccavity. Such measuring can be performed using a sensor on theventilation device and where measuring the state of air flow within thethoracic cavity comprises detecting airflow, pressure, and/or volumeusing the sensor. Moreover, the sensor can monitor a direction of airflow.

The timing of the artificial ventilation can be altered by using thesensor to determine when a pressure in the body passageway increases anddelivering air for automatically ventilating the individual when thepressure in the body passageway increases, or at least before thedecrease, the pressure of the ventilations acts like and internal chestcompression, then the recoil of the chest draws the air into the lungs.

The methods can further include providing a feedback based on measuringthe condition of the thoracic cavity. Such feedback can includeinformation regarding the compression, where the information is selectedfrom a phase, rate, efficiency, depth, and timing. The feedback can alsobe based on measuring the condition of the thoracic cavity comprisesmeasuring a quality of the chest compression by determining a change ina volume of air in the thoracic cavity. In some variation, the feedbackcomprises information to increase or decrease a compression applied to achest of the patient.

Variations of the method include altering the timing of the ventilationto initiate automatic ventilating of the individual when a pressureincreases, decreases, or reaches a maximum pressure in the bodypassageway. The method can further comprise continuing measuring thecondition of the thoracic cavity to determine the change in the thoraciccavity after altering the timing of automatically ventilating of theindividual and reverting to automatically ventilating the individual atthe predetermined timing upon failure to detect the change in thethoracic cavity.

In an additional variation, the method can further include adjusting theventilating device to suspend automatically ventilating the individualand manually ventilating the individual while maintaining suction tomaintain the vacuum if the vacuum is detected.

The methods described herein can include a mask that is slidablypositioned along the ventilation device and where the mask can bepressed against the individual with a manual actuator or trigger toisolate the respiratory opening of the individual from an externalatmosphere. Typically, the mask will not be sealed against the patientduring the automatic assisted ventilation. Therefore, during CPR thesystem is open. Sealing the mask against the patient and initiating amanual trigger can close the system and administering a bolus of air tomanually ventilate the patient.

The methods described herein can further include electricallystimulating a heart of the individual using the ventilation device.

In another variation, the method of artificially ventilating anindividual can comprise inserting a ventilation device within arespiratory opening of the individual and positioning a working end ofthe ventilation device within a body passageway of the individual, theventilation device having a pressure sensor configured to detectpressure changes within the body passage; delivering a bolus of air intoan airway the individual at a pre-determined rate; altering thepre-determined rate by delaying delivery of the bolus of air when thesensor detects a pressure change in the air within the body passage,where the pressure change within the body passage results from a chestcompression.

The method can further comprise delivering the bolus of air into theairway of the individual occurs after a pre-determined delay. In somevariations, the sensor is configured to intermittently detect pressurechanges within the body passageway.

In another variation, the method further comprises, after altering thepre-determined rate, the ventilation device resumes delivering the bolusof air at the pre-determined rate if the pressure sensor fails to detecta pressure range within a first period of time.

In another variation, the method for ventilating an individual includesinserting a ventilation device within a respiratory opening of theindividual and advancing a working end of the ventilation device withina body passageway of the individual, where the working end includes afirst opening fluidly coupled to a first lumen and a second openingfluidly coupled to a second lumen, where the second opening is locatedalong the ventilation device proximal to the first opening; drawingsuction through the first opening to induce collapse of the bodypassageway and maintaining the suction for a period of time; monitoringa fluid parameter to determine whether the body passageway collapses;automatically ventilating the individual through the second lumen upondetecting collapse of the body passageway and maintaining suction tomaintain the collapse of the body passageway; and automaticallyventilating the individual through the first lumen upon failure todetect collapse of the body passageway; wherein delivery of a bolus ofair during automatically ventilating the individual occurs at a firsttiming; measuring a condition of a thoracic cavity to determine a changein the thoracic cavity; and altering the timing of the delivery of thebolus of air during automatically ventilating the individual upondetecting the change in the condition thoracic cavity.

In another variation, the present disclosure includes a method forartificially ventilating an individual by coupling a ventilation deviceto a respiratory opening of a respiratory passage of the individual;positioning a pressure sensor in fluid communication with therespiratory passage, the pressure sensor configured to detect pressurechanges within the respiratory passage; delivering a bolus of air intothe respiratory passage of the individual at a pre-determined rate; andaltering the pre-determined rate by delaying delivery of the bolus ofair until the sensor detects a pressure change in the air within therespiratory passage, where the pressure change within the respiratorypassage results from a chest compression. Such a method can include anydevice, including conventional ventilation devices.

The present disclosure also includes a system for artificiallyventilating an individual using a source of oxygen, the systemcomprising: a ventilation device having a pressure sensor configured todetect pressure changes within the body passage, the pressure sensorbeing positioned on a portion of the device configured to be insertedinto a body passageway of the individual; a controller configured todeliver a bolus of air into an airway the individual at a pre-determinedrate, where the controller is configured to monitor the pressure sensorand upon detecting a pressure change, the controller alters thepre-determined rate by delaying delivery of the bolus of air.

The present disclosure also includes devices for ventilating anindividual. In one example such a device comprises a tubular memberhaving at least a first and second lumen, where the first lumen isfluidly coupled to a first opening located distally relative to a medialopening, where the medial opening is fluidly coupled to the secondlumen, where the first opening and medial opening are each fluidlyisolated within the tubular member; the tubular member being configuredto measure a condition of a body lumen to determine a change in athoracic cavity of the individual; a control system having a suctionsource and a gas supply lumen, the control system having a valveconfigured to fluidly couple the gas supply lumen to either the firstlumen or to the second lumen; the control system also capable of drawingsuction from the suction source through the first opening and firstlumen, where the control system is configured to monitor the first lumenfor a vacuum to indicate collapse of the body passageway and formationof a seal at the first opening; where the control system is furtherconfigured to selectively form a ventilation path from the supply lumento the first lumen or second lumen by selecting the first lumen as theventilation path if collapse of the body passageway is not detected; andselecting the second lumen as the ventilation path if collapse of thebody passageway is detected; where the control system is configured toautomatically ventilate the individual through the ventilation path at afirst rate; and where the control system is further configured to alterthe first rate upon detecting the condition of the body lumen.

The system and methods described herein can be compatible with devicesthat monitor the concentration or partial pressure of carbon dioxide(CO2) in the respiratory gases (capnography). Primarily such devices aremonitoring tool for use during anesthesia and intensive care thatmonitor expiratory CO2 are of interest when rebreathing systems arebeing used. The ability to integrate the ventilation systems describedherein with such capnography systems allows for improved patient care.Furthermore, the systems and methods described herein can be compatiblewith equipment found in emergency vehicles such as oxygen suppliesand/or power supplies. In some variations, the system of the presentdisclosure can also provide audio or even video (through use of adisplay screen) instructions to ensure proper operation in thosesituations where the system may be used by first responders that are nottrained emergency personnel.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is best understood from the following detailed descriptionwhen read in conjunction with the accompanying drawings. It isemphasized that, according to common practice, the various features ofthe drawings are not to-scale. On the contrary, the dimensions of thevarious features are arbitrarily expanded or reduced for clarity. Alsofor purposes of clarity, certain features of the invention may not bedepicted in some of the drawings. Included in the drawings are thefollowing figures:

FIG. 1 provides a partial view of a patient's oral cavity, tongue,pharynx as well as esophagus and trachea.

FIG. 2 illustrates one example of a conventional device as used tointubate a patient.

FIG. 3 illustrates various components of an example of an improvedventilation system.

FIGS. 4A to 4C illustrate a partial sectional view of a working end ofan improved ventilation device.

FIGS. 5A to 5E show a representation of the process of ventilating apatient using an improved ventilation device.

FIGS. 6A to 6C show additional variations of a working end of aventilation device.

FIG. 7 illustrates a schematic of an electrically powered system.

FIG. 8A shows an example of a component schematic for a pneumaticallydriven system as described herein.

FIG. 8B provides a component listing for the schematic of FIG. 8A.

FIG. 8C shows a listing of various modes for the system.

FIGS. 8D to 8M illustrates various flow paths for the various modes ofoperation.

FIG. 9A illustrates another variation of a device useful for providingassisted ventilation with improved outcomes by monitoring a condition ofthe thoracic cavity.

FIGS. 9B to 9C show a partial isometric view and partial cross sectionalviews of the mask and trigger used to close the system and initiatemanual ventilation.

FIG. 9D illustrates a condition where a trigger in the system fluidlycloses by closing the exhaust port.

FIGS. 10A and 10B illustrate examples of the working end of the devicewhen inserted into a body passageway of an individual and monitoring acondition of the thoracic cavity.

FIGS. 11A and 11B illustrate a variation of a system for artificiallyventilating an individual using a source of oxygen, such as thosedescribed herein.

FIG. 11C shows an external device being used to control the ventilatordescribed herein.

FIG. 12 provides a schematic of a control system relying on the gassupply to provide a source for both ventilation and suction.

FIGS. 13-22 illustrate an example of the circuitry for sensing thephase, rate, depth and effectiveness of a chest compression with aresistor placed on the tube of an airway placed in the patient's mouth,trachea or esophagus

DETAILED DESCRIPTION OF THE INVENTION

Before the devices, systems and methods of the present invention aredescribed, it is to be understood that this invention is not limited toparticular therapeutic applications and implant sites described, as suchmay vary. It is also to be understood that the terminology used hereinis for the purpose of describing particular embodiments only, and is notintended to be limiting, since the scope of the present invention willbe limited only by the appended claims.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. The terms “proximal”, “distal”,“near” and “far” when used indicate positions or locations relative tothe user where proximal refers to a position or location closer to theuser and distal refers to a position or location farther away from theuser.

FIG. 3 illustrates various components of an example of an improvedsystem according to the present disclosure. As shown, the ventilationdevice 100 includes a working end 102 that is inserted into a patient.The working end can include a distal tubing 104 that contains a firstlumen (not shown), which extends through a distal opening 106 of theventilation device 100 and is in fluid communication with a control unit(also called a ventilator) 150 and/or supply source 160 via one or moreproximal tubes 118. The control unit 150 can also include an apparatusdesigned to provide suction as well as a collection canister. Inoperation, the control unit 150 directs suction or applies a vacuumthrough a first fluid path 122, which in turn causes a suction ornegative pressure at the distal opening 106. The source 160 can compriseoxygen, air, or any other gas that is desired for ventilation ofdelivery into the lungs. The source 160 can be nested within physicalconstruct of the controller 150. However, the source 160 can be optionalso that the controller ventilates the patient only using ambient air.

The control unit 150 maintains the device 100 in this state for a setperiod of time and monitors the parameters of the pressure or flowparameters within the first lumen to determine whether to ventilatethrough the first or second. The example illustrated in FIG. 3 alsoincludes a hub 108 with one or more features that aid in properfunctioning of the device. Such features are described in detail below.Furthermore, the distal opening 106 can include any number of ports atthe distal end of the device so long as the ports are in a fluid pathwith the first lumen. Likewise, the medial opening 112 can comprise anynumber of openings as long as those openings are in fluid communicationwith the second lumen. In addition, variations of the device can also beinserted through a nasal opening rather than a mouth.

The ventilation device 100 further includes a proximal tubing 110 thathouses a second lumen (not shown) that exits the device 100 at a medialopening 112. As discussed below, distal opening and first lumen arefluidly isolated from the medial opening and second lumen through theworking end of the device 102 to the control unit 150. This fluidisolation allows the control unit 150 to determine which lumen to use toventilate the patient. The control unit directs flow through a secondfluid path 124 that is fluidly coupled to the second lumen and medialopening 112 when the device is positioned in the esophagus 16 ratherthan the trachea 18.

The ventilation system 100 illustrated in FIG. 3 also shows an optionalmask 114 with optional venting ports 116. Variations of the system caninclude alternate configurations without a mask or with other suchdevices such as a mouth guard or any other commonly used mountingapparatus. As discussed below, the mask 114 or other mounting apparatuscan be used to assist the caregiver in properly orienting the device 100as it is inserted into the patient. Variations of the device can includea balloon, sponge or any other structure that secures the proximalregion of the device to the patient to ensure that gas is directed tothe lungs during inhalation. The mask (or other structure as describedherein) can include a securing band, tape strip, or temporary adhesiveto secure the mask in place on the patient. The mask or similar featurecan be used to determine how far to advance the working end 102 into thepatient. Alternatively or in combination, the device 100 can includegraduated markings 134 to assist the caregiver in properly advancing thedevice into the patient. The mask can be slidable to adjust the lengthfrom the mask to the distal or proximal opening.

FIG. 3 also shows a representative figure of a control system 150 with anumber of controls 152 that allow for various device operativesequences, manual controls, or device overrides. For example the system150 can include manual ventilation controls so that the caregiver canmanually adjust inspiration and expiration of the patient. The controls152 can include a reset or rapid ventilation mode for performing cardiopulmonary resuscitation. The controls 150 include a continuous airflowor continuous vacuum mode that can assist in clearing debris or bodilyfluids from the body passages. The controls also allow caregivers toconnect the device 100 directly to an endotracheal tube if the caregiverdecides to intubate. In an additional variation, the system can allowfor active ventilation consisting of blowing for a period and thensucking for a period through the active lumen in order to increaseventilation efficiency. In some variations, the system is configured sothat the ventilation openings, as well as other openings on the tube donot rotate relative to the mask so that caregiver can align the openingswith the trachea.

The device shown in FIG. 3 can also include one or more electrodespositioned on the working end. For example, the hub 108 can serve as anelectrode and apply electricity to the heart in order to defibrillate apatient out of an irregular rhythm or increase the heart rate orcontractility. Additionally, one or more electrodes can be inserted onor embedded in a tube designed to be placed in the patient's mouth,esophagus or trachea. Such placement will be beneficial because it wouldallow the operator a more direct route of electrical stimulation of theheart compared that the current use of pads placed on the patient'schest. A tube placed in the esophagus would more easily be able todetect a pulse because of the major arteries running parallel to theesophagus. This would allow rescuers to determine a pulse without havingto touch the patient. It would also allow an untrained bystander toadminister CPR who was not trained on checking for pulsed. In addition,the pressure sensors, as described below, can be placed on the tube thathad been advanced into the patients mouth that may be pressing againstmajor arteries would be able to detect if there was a change inpressure.

In additional variations, the control system 150 can be integrated intoone or more parts of the device body 102 rather than being a separatestand-alone box type configuration. In addition, the ventilation system100 can be optionally configured to work with a defibrillator. Alternatevariations of the system 100 can be configured to provide an audible,visual, or tactile sensation to indicate when a caregiver shouldadminister chest compressions.

FIG. 3 also shows the depicted variation of the device 100 as having anoptional balloon 132 or other expandable member located on a workingend. When used, the balloon can be positioned anywhere along the deviceadjacent to the distal opening 106. Alternatively, or in combination, aballoon can be located adjacent to the medial opening.

The various tubing forming the device 100 should be sufficientlyflexible so that the device can be navigated through the upperrespiratory system. Alternatively, or in addition, portions of thetubing can be constructed to withstand being collapsed by the patient'smouth or teeth. In additional variations the system 100 can be designedsuch that the distance between the distal opening 106 is adjustablerelative to the medial opening 112 and/or the mask 114 (or even moveablerelative to the gradiations 134). A similar variation includes a medialopening 112 that can be adjustably positioned relative to the distalopening 106, mask 114 and or gradiations 134

FIGS. 4A to 4C illustrate a partial sectional view of an airway unit orworking end 102 of a ventilation device 100 as described herein.

FIG. 4A illustrates a first lumen 128 that is fluidly coupled to adistal opening 106 and a second lumen 130 that is fluidly coupled to themedial opening 112 where the first and second lumens 128 and 130 arefluidly isolated from each other as described above. FIG. 4A alsoillustrates that the spacing 126 between the distal opening 106 and themedial opening 112 can be selected based on the intended patient. Forexample, since the medial opening 112 is intended to be positioned in oraround the pharynx when the distal opening 106 is positioned in theesophagus or trachea, the spacing 126 can be selected for an individualof average build. In most cases, the working end 102 of the ventilationdevice 100 will comprise a single use disposable component. Accordingly,the ventilation device 100 can include a number of disposable componentshaving different spacing 126 between the medial 112 and distal 106openings. For instance, the varying spacing can accommodate infants,toddlers, young children, as well as various body sizes.

FIG. 4B illustrates a partial cross sectional view of the working end102 of the ventilation device of FIG. 4A. Once the device is properlypositioned within the patient, the control unit 150 applies a suction orvacuum through a first fluid path 122, then through the first lumen 128and ultimately causing a vacuum at the distal opening 106 as denoted byarrows 30. In additional variations, the operator or caregiver maychoose to clear food or other debris from the patient by delivering airthrough the first lumen 128 or by attempting to use the suction at thedistal opening to remove particles or other bodily fluids. The system150 shall continue to pull a vacuum through the first lumen 130 for aperiod of time. If the device 100 is properly positioned within thetrachea (as discussed below), the system 150 will begin to ventilatethrough the first lumen 128. In other words, the system 100 will beginto cyclically deliver oxygen or other gas from the source 160 and removecarbon dioxide from the patient to properly ventilate the patient'slungs. In this situation, flow is not required through the second lumen130 and medial opening 112. Although FIG. 4B shows the first lumen 128to be located within the second lumen 130 any number of variations canbe used. For example, the lumens can be concentric or parallel.Additional variations even allow for the lumens to be in fluidcommunication where one or more valves determine whether ventilationoccurs through the distal opening or through the medial opening. Thedevice can include any number of safety checks to confirm placement ofthe device doesn't change. For example, once the device confirmsplacement in the trachea, it can re-perform a check to ensure that it isplaced in the trachea over a pre-determined interval. Alternatively, itcan perform this check on a sliding scale (e.g., 1^(st) check at 30second, 2^(nd) check at 2 minutes, 3^(rd) check at 10 minutes, etc.). Inan additional variation, the system is designed to provide a safetycheck to ensure that the suction filter is not clogged causing a misreadof position. In such a case the device gives ventilation out the distalport once a vacuum is detected. This ventilation bolus can be small orlarge. By monitoring vacuum and determining if it is lost during thedistal air bolus, the device knows that the seal was at the esophagusand resumes suctioning distally and ventilation through the proximalports. If the vacuum is not lost during the distal air bolus the devicecan assume that the filter is clogged and an error signal will indicatefor the operator to replace the working end of the device or to checkfor obstructions.

The system 150 can comprise the mechanism that ventilates and producessuction or a vacuum. Generally, the system 150 is reusable (as opposedto the working end that is generally disposable). The system 150 can beportable, affixed to an ambulance or other emergency vehicle or buildwithin a cart or room. Variations include battery powered devices,pneumatic powered devices, or devices that require a power source (suchas an AC outlet).

FIG. 4C illustrates the condition where the distal opening 106 ispositioned within the esophagus. In this situation the control unit 150directs ventilation through the second lumen 130. As shown by arrows 32,because the medial lumen 112 is fluidly coupled to the second lumen 130ventilation 32 takes place at the medial opening 112.

FIGS. 5A to 5E show a representation of the process of ventilating apatient using a ventilation device 100 as described herein.

FIG. 5A illustrates the ventilation device 100 as a caregiver advancesthe device 100 into the oral cavity 10 over the tongue 12 and into thepharynx 14. At any time during the procedure, the caregiver can manuallyoperate the device to suction fluids, food particles, or other itemsfrom the body. As described herein, the caregiver can “blindly” advancethe working end 102 into the patient. As a result, the working end 102will either end up in the esophagus 16 or trachea 18 of the patient.

FIG. 5B illustrates the condition where the caregiver advances theworking end 102 into a trachea 18 of an individual. Once the caregiverplaces the device 100, the caregiver can initiate the control unit 150to start the process to determine placement of the device 100.Alternatively, one or more sensors on the device can automaticallytrigger actuation of the control unit. In either case, the control unitdraws a vacuum through the distal opening 106 for a predetermined periodof time. The vacuum reduces pressure and draws air within the distalopening 106. The control unit 150 then assess a state of the device bymonitoring the vacuum, airflow, or any other fluid parameter that wouldindicate whether the walls of the body passage, in this case the trachea18, collapsed causing the formation of a vacuum seal. In those caseslike FIG. 5B where the device is situated within the trachea, thesuction 30 will have little effect on the walls of the trachea 18. Asnoted above, the walls of the trachea 18 are reinforced with rings ofcartilage 20 that provide structural rigidity of the airway. Because thecontroller 150 will not detect the formation of a vacuum seal at thedistal opening 106 (or within the first lumen) the system registers thedistal opening 106 as being properly positioned in the trachea 18(rather than the esophagus 16) and, after a pre-determined period oftime (e.g., 10-15 seconds), the controller 150 ceases to draw a vacuumand begins to ventilate the patient's lungs by alternating betweendelivery of the gas from the gas supply 160 and removing carbon dioxide.As a result, the first lumen is used as a ventilation lumen. It will beimportant for the controller 150 to differentiate changes in vacuum orflow that result from suctioning of fluids or debris. In some variationsof the device, the controller 150 is configured to identify formation ofa seal when the vacuum builds or flow drops to a sufficient degree suchthat the device has formed a vacuum seal rather than suctioned fluids ora substance.

The control unit 150 can determine whether or not a seal is formed bymeasuring strain on a suction motor (or similar apparatus such as aventuri device that produces a vacuum) that causes the negative pressurewithin the main lumen for suction. If the control unit 150 observes zeroor minimal strain on the suction motor after a pre-determined time, thenthe control unit 150 will use the first lumen as the ventilation lumen.

FIG. 5D illustrates a state where the caregiver advances a working end102 of the ventilation device 100 into an esophagus 16 rather than thetrachea 18. Similarly to the state depicted by FIG. 5B above, once thecaregiver positions the device 100, the caregiver can initiate thecontrol unit 150 to start the process to determine placement of thedevice 100. As noted above, additional variations of the device andsystem can include one or more sensors that can automatically triggeractuation of the control unit.

FIG. 5D depicts the state where the control unit 150 pull vacuum throughthe distal opening 106 for a predetermined period of time. The vacuumreduces pressure and draws air within the distal opening 106. Thecontrol unit 150 then assess a state of the device by monitoring thevacuum, airflow, or any other fluid parameter that would indicatewhether the walls of the body passage, in this case the esophagus 16collapsed. As shown, the walls partially or totally collapse resultingin formation of a vacuum seal at the distal opening 16. As noted above,muscles form the walls of the esophagus 16. There is no reinforcingstructure in the esophagus as opposed to the cartilage rings in thetrachea 18. The control unit can be configured to monitor the formationof a vacuum seal and if the seal remains for a predetermined period oftime, the control unit 150 directs ventilation 40 in and out of themedial opening 112 as depicted in FIG. 5E. As shown and discussed above,the spacing between the distal opening 106 and medial opening 112 can beselected such that the medial opening remains in or near the pharynx 14.However, variations of the device permit the medial opening to enter theesophagus 16 so long as the opening 112 can continue to ventilate thepatient.

Because the control unit 150 will not detect the formation of a vacuumseal at the distal opening 106 (or within the first lumen) the systemregisters the distal opening 106 as being properly positioned in thetrachea 18 (rather than the esophagus 16) and, after a pre-determinedperiod of time, the control unit 150 ceases to draw a vacuum and beginsto ventilate the patient's lungs by alternating between delivery of thegas from the gas supply 160 and removing carbon dioxide. In thissituation the device uses the second lumen as a ventilation lumen. Oneadditional benefit of positioning the working end 102 of the device 100within the esophagus 16 is that the vacuum seal produces an anchoringeffect that maintains the device in position. This feature eliminatesthe need to secure the mask or other feature about the patient's head,neck or face. In addition, if a caregiver inadvertently pulls the device100 while a seal is formed, the vacuum seal is simply broken and thedevice releases from the esophagus 16. This provides a safetyimprovement over conventional ventilation devices that rely on anexpandable balloon, which if pulled, can cause trauma to the patient'sairways, vocal cords, or other structures.

In certain variations, the device 100 shall cease ventilating after aperiod of time and produce suction through the distal opening. Such astep is considered a safety feature in the event that the working end ismoved, repositioned, etc.

FIGS. 6A to 6C show variations of the working end 102 of a ventilationdevice as described herein. FIG. 6A illustrates a hub having an opening106 that is surrounded by a contoured surface. The contoured surface canassist reducing the chance that the distal opening 106 becomes cloggeddue to food particles or other fluids. This feature also assists inreducing the occurrences that the control unit misreads an opening 106that is obstructed (with food particles or other bodily fluids) for anopening that formed a seal with the walls of the esophagus. FIGS. 6B and6C illustrate additional variations of a working end 102 of aventilation device. In these variations, the working end 102 can befabricated with or without a hub. FIG. 6B illustrates a straight tubehaving a plurality of openings 106. FIG. 6C illustrates a beveled endhaving an opening 106.

As noted above, the device described herein can be pneumatically drivenusing compressed gas and valves or electrically controlled. FIG. 7illustrates a schematic of an electrically powered device using asuction motor, air compressor and circuitry to switch between a firstfluid path 122 (ultimately fluidly coupled to a distal opening) and asecond fluid path 124 (ultimately fluidly coupled to a medial opening).

FIG. 8A shows an example of a component schematic for a system asdescribed herein that is pneumatically driven. FIG. 8B provides a listof the components found in FIG. 8A. The valves operate in multiplestates based on the conditions discussed above. The followingdescription illustrates an example of the different states of thecomponents found in the component schematic of FIG. 8A.

Medial Supply Valve P1 (4/2);

State 1 (nominal, spring return): Controls the 15 s timing of vacuumsupply through Distal Supply Valve P2;

State 2 (actuated): Provides supply for medial ventilation;

Pilot Actuation: 10″Hg vacuum

Distal Supply Valve P2 (4/2)

State 1 (nominal, spring return): Provides supply for Vacuum Generator;

State 2 (actuated): Provides Supply for Distal Ventilation;

Pilot Actuation: 40 psi from flow-controlled output of Medial SupplyValve, State 1.

Pulse Valve P3 (3/2 Normally Open);

State 1 (nominal, spring return): Fills Accumulator volume atflow-controlled rate until set pressure is achieved at inline ReliefValve;

State 2: (actuated): Dumps accumulator volume to Ventilation SelectorValve through quick exhaust;

Pilot Actuation: 5 psi from output of inline Relief Valve

Ventilation Selector Valve P4 (3/2 Fully Ported);

State 1 (nominal, spring return): Routes output of Pulse Valve to MedialVentilation Output;

State 2: (actuated): Routes output of Pulse Valve to Distal VentilationOutput;

Pilot Actuation: 40 psi from output of Distal Supply Valve, State 2

Operation Valve M1 (Manual Toggle, 3 position, All Detent);

State 1 (toggle down, “ON”): Provides supply for Medial Supply Valve andDistal Supply Valve;

State 2 (toggle centered, “OFF/RESET”): Blocks supply, vents system;

State 3 (toggle up, “VACUUM”): Bypasses all valves, provides supply toVacuum Generator.

Mode Valve M2 (Manual Toggle, 3 position, Detent/Detent/Momentary);

State 1 (toggle down, detent, “VENTILATE”): Provides supply for PulseValve and Ventilation Selector Valve;

State 2 (toggle centered, detent, “BYPASS”): Blocks supply to PulseValve and Ventilation Selector Valve.

State 3 (toggle up, momentary spring return, “ON-DEMAND”): Blocks supplyto Pulse Valve, provides continuous flow-controlled supply toVentilation Selector Valve

The system illustrated by the component schematic of FIG. 8A can have avariety of modes of operation. In one example, as shown by FIG. 8C, thesystem can include 8 separate modes of operations controlled by theposition of various valves and the operation state of a medial supplyvalve.

Mode 0, where the system is set to an Off position.

M1 set to OFF;

Main supply blocked; system vented;

FIG. 8D shows Mode 1, where there is a continuous vacuum applied throughthe sytem.

M1 set to VACUUM

Ventilation system bypassed; vacuum at Vacuum Output; Vacuum Indicatoron

FIG. 8E shows Mode 2, where the system engages in placement detection;

M1 set to ON;

Vacuum at Vacuum Output until P2 pilot activated (15 s); VacuumIndicator on;

In Mode 3, the system engages in ventilation through the distal opening.

M1 set to ON; M2 set to VENTILATE;

No vacuum detected; P2 pilot activated; P4 pilot activated.

FIG. 8F shows Mode 3A, where an accumulator fills at controlled rate(0.67 s) until inline Relief Valve activates (30 psi);

Distal Ventilation Indicator on.

FIG. 8G shows Mode 3B: P3 pilot activates, closing P3 and exhaustingAccumulator volume through Quick Exhaust to P4; Distal VentilationIndicator on.

Mode 4—Medial Ventilation

M1 set to ON; M2 set to VENTILATE

Vacuum detected; P1 pilot activated; vacuum at Vacuum Output.

FIG. 8H shows Mode 4A where accumulator fills at controlled rate (0.67s) until inline Relief Valve activates (30 psi);

Vacuum Indicator on;

Medial Ventilation Indicator on.

FIG. 8I shows Mode 4B: P3 pilot activates, closing P3 and exhaustingAccumulator volume through Quick Exhaust to P4;

Vacuum Indicator on; Medial Ventilation Indicator on.

FIG. 8J shows Mode 5—Ventilation Bypass (Distal);

M1 set to ON; M2 set to BYPASS;

No vacuum detected; P2 pilot activated; P4 pilot activated; supply to P3& P4 blocked; Distal Ventilation Indicator on.

FIG. 8K shows Mode 6—On-Demand Ventilation (Distal);

M1 set to ON; M2 set to ON-DEMAND;

No vacuum detected; P2 pilot activated; P4 pilot activated; supply to P3blocked; continuous flow-regulated flow to P4; Distal VentilationIndicator on

FIG. 8L shows Mode 7—Ventilation Bypass (Medial);

M1 set to ON; M2 set to BYPASS;

Vacuum detected; P1 pilot activated; vacuum at Vacuum Output;

supply to P3 blocked;

Vacuum Indicator on;

Medial Ventilation Indicator on

FIG. 8M shows Mode 8—On-Demand Ventilation (Medial);

M1 set to ON; M2 set to ON-DEMAND;

Vacuum detected; P1 pilot activated; vacuum at Vacuum Output;

supply to P3 blocked;

continuous flow-regulated flow to P4; Vacuum Indicator on; MedialVentilation Indicator on.

FIG. 9A illustrates another variation of a device useful for providingassisted ventilation with improved outcomes. The features and aspect ofthe illustrated example can be combined with any of the variations ofthe devices described herein. Moreover, the features of the devicesdescribed herein that improve the effectiveness of assisted ventilationcan be used with conventional assisted ventilation devices.

As illustrated, assisted ventilation device 100 includes a working end102 that is inserted into a patient. The working end can include adistal tubing 104 that contains a first lumen (not shown), which extendsthrough a distal opening 106 of the ventilation device 100 and is influid communication with a control unit (also called a ventilator) 150and/or supply source 160 via one or more proximal tubes 118. The controlunit 150 can also include an apparatus designed to provide suction aswell as a collection canister (not shown). As noted above, the device100 can optionally include an improved control unit 150 that directssuction or applies a vacuum through a first fluid path 122, which inturn causes a suction or negative pressure at the distal opening 106.The source 160 can comprise oxygen, air, or any other gas that isdesired for ventilation of delivery into the lungs. The source 160 canbe nested within physical construct of the controller 150. However, thesource 160 can be optional so that the controller ventilates the patientonly using ambient air. FIG. 9A also illustrates the device 100 asincluding features that allow the assisted ventilation device 100 todeliver ventilation in a manner that improves the efficiency of theassisted ventilation procedure.

For example, the improved device 100 can include one or more structuresused to determine a change in the thoracic cavity. Such changes caninclude physical movement of the tissues within the thoracic cavity, theforce applied to the working end 102 of the device 100, and/or thedeflection of any part of the device 100. Alternatively, or incombination, a change in the thoracic cavity can comprise a change inthe fluid environment of the thoracic cavity, including any bodypassageways that are in fluid communication with the thoracic cavity,e.g., the airway, the esophagus, etc.

FIG. 9A illustrates the device 100 as being able to measure fluidparameters in the thoracic cavity via a sensor 180 located along aportion of the working end 102 of the device. Although the sensor 180 isillustrated on the proximal tubing 110, the sensor 180 can be positionedalong any portion of the device 100 that enables monitoring of the fluidparameters of the thoracic cavity and/or body passage in fluidcommunication with the thoracic cavity. For instance, the device 100 caninclude one or more sensors 180 positioned along the distal tubing 104and/or hub 108. Moreover, variations of the device include one or moresensors positioned within the device 100.

The sensor 180 can comprise a pressure sensor, flow sensor, transducer,or similar structure. Alternatively, in additional variations, thesensor 180 can comprise a lumen or passageway having an open endpositioned as described above, where the lumen or passageway extendsthrough the device via a sensor tubing 182 that allows the actual fluidparameters to be read by the actual sensor located within the device100, tubing 118, and/or control unit 150.

The variation illustrated in FIG. 9A also shows a sensor 180 that is notflush with the proximal tubing 110 of the device 100. As shown, themeasurement surface (e.g., the actual sensor or the sensor lumen 184 canbe positioned so that tissue adjacent to the device 100 does not obscureor affect the readings of the sensor. However, additional variations ofthe device 100 include sensors that are flush with the device body. Inaddition, pressure from the device 100 (e.g., the proximal tube 118 canbe used to deliver air to the sensor 180 reduce obstructions frominterfering with the measurement of any fluid parameter in the bodylumen.

FIG. 9A also illustrates a force detecting component, such as a straingauge, optic fiber, transducer, or similar force/movement detectingstructure that can be located anywhere along the working end 102 of thedevice 100. The force detecting component 190 is shown as being on thedistal tubing 104, however, one or more force detecting components 190can be positioned along any portion of the device as long as thecomponent 190 detects a force applied to the chest via a resulting forcebeing applied to the device through movement of the tissue displaced byassisted chest compression.

The presence of both the sensor 180 and the force detecting component190 on a single device is for purposes of illustration only. Certainvariations of the device can include any combination of force detectingcomponent, sensor, or both.

FIG. 9A also shows the device as including a manual ventilation trigger186. In operation, the medical caregiver can use the manual ventilationtrigger 186 to manually deliver a bolus of air through the device 100.Alternatively, or in combination, the manual ventilation trigger 186 canactivate the sensor 180 or force detecting component 190 to deliver abolus of air on demand. Such a feature can be useful if the care giverhas obtained a pulse and intends on delivering assisted ventilationalone. Alternatively, the caregiver can use the manual ventilationtrigger 186 to deliver a bolus of air through any part of the device inan attempt to clear bodily fluids that might otherwise obstruct thedevice. The manual ventilation trigger 186 can operate as the deviceperforms the automated assisted ventilation where a bolus of air isdelivered at certain period of time. Alternatively, or in combination,the manual ventilation trigger 186 can deliver a bolus of air when theventilation device 100 (or controller 150) is placed in a manual-mode.

In certain variations of the device, when initiating the manual trigger186, the device be programmed to maintain ventilation through therespective opening that was selected in the automatic mode. For example,if the device is placed in the esophagus, and then switched to manualoperation, the control system can maintain suction to ensure that theesophagus closes the distal opening and forms a vacuum so that manualventilation automatically proceeds through the proximal or medialopening 112. Likewise, if the device is positioned in the trachea,actuating the device in a manual mode will cause the bolus of air to beexpelled from the distal opening of the device.

In one example, the trigger 186 comprises a hollow button, attached tothe device and inline with the tubing that connects to the sensor 180.When the button is pressed it sends an air bolus to the sensor 180 thatsignals the control system 150 to start assisted ventilation. The volumeof air provided by the manual trigger 186 can be preset. Alternatively,air can be delivered until the caregiver releases the trigger 186 tostop the ventilation. In addition, mounting the trigger 186 mounted onthe mask 114 is beneficial because it allows the caregiver to ensure themask 114 is sealed against the patient's face with one or two handswhile operating the demand ventilations.

The manual trigger 186 can also operate to with one or more one-wayvalves (e.g., a flap that allows exhaust of air when the trigger 186 isnot pressed). This ensures that there is no excess buildup of pressurein the airway and prevents barotrauma. This also allows spontaneousbreathing. When the ventilator is switched to demand ventilation modethe lungs need to be isolated from atmosphere during the inhalationperiod only. This can be achieved by having the demand ventilationtrigger 186 mounted on a flap that is above an opening on the mask. Theflap is designed to be opened with when no pressure is being applied tothe button, then once pressure is applied to the trigger the flap issealed against the opening, closing the system and allowing air toinflate the lungs. When the button is released for exhalation the flapis comes off the mask opening allowing air to escape and lungs deflate.

FIG. 9B illustrates a variation of a portion of a device 100 showing amask 14 having a trigger 186 that is coupled to an exhaust port 116. Inthis variation, the mask 114 also includes one or more pressure releasevalves 117 that will crack or permit flow beyond an establishedpressure. Such a fail-safe presents unsafe pressurization of the airwayby the device. The pressure release valves 117 can be surrounded byprotrusions or features 115 that prevent objects from blocking thevalves 117. The device 100 is also shown with an adjustment control 183that permits movement of the mask 114 along the tube 110. FIG. 8B alsoillustrates a tubing 185 that couples the trigger 186 to the sensorlumen 184. As shown, the sensor lumen 184 can be coupled with at-fitting or other fluid coupling so that a portion of the lumen is influid communication with the trigger 186 as described below.

FIG. 9C illustrates a partial cross sectional view of the mask 114 andtubing 110. As shown, when the mask is positioned against therespiratory opening of the patient (i.e., a mouth or nose), airflow fromthe expiratory cycle (represented by arrows 109) flow through a portionof the mask 114 and into a chamber 113 that is in fluid communicationwith the exhaust lumens 117. However, in this condition, the trigger 186is not being pressed against the mask 114 such that the exhaust port 116remains open allowing airflow 109 to exit the mask. Furthermore, thetrigger 186 can be positioned in a shaft having a compressible airvolume 111 that is in fluid communication with the tubing 185.Accordingly, although the mask 114 is pressed against the patient, theexhaust port 116 permits the system to be open (fluidly open).

FIG. 9D illustrates a condition where the trigger is pressed or actuated(the trigger can be on a spring return or have elasticity to function asa spring return). Once actuated, the trigger 186 fluidly closes thesystem by closing the exhaust port 116. The action of the trigger 186can also be used initiate a manual bolus of air through the tubing 110.For example, the trigger 186 can have one or more electrical contacts orswitches in region 111 that provides a signal to the control system todeliver a bolus of air. In an additional configuration, actuation of thetrigger 186 compresses the volume of air in space 111 causing a pressureincrease P2 in tube 185, which is coupled to the sensor lumen 184, thisincrease in pressure causes the sensor lumen to perform a manualventilation by delivering a bolus of air through the tubing 110.Likewise, when the trigger 186 is released, the expansion in volume ofregion 111 creates a drop in pressure in tubing 185 as well as in thesensor lumen 184, where the drop in pressure is registered by the sensorto stop ventilation.

In addition to the sensor 180 and/or sensor lumen 184 the device 100 caninclude any number of additional lumens to provide information tomonitoring equipment. For example, the device can include one or morelumens that are fluidly coupleable to a capnograph device.Alternatively, or in combination, the sensor lumen 184 can also allowfluid coupling to a monitoring device. In such a case, the lumens can becoupled to one or more openings (such as 180) located on the working endof the device.

FIG. 10A illustrates an example of the working end 102 of the device 100when inserted into a body passageway of an individual. In this example,the device is inserted into a trachea 18, where the device 100 detectsthat it is in an airway as described above. However, as shown in FIG.10B, variations of the device 100 can also be positioned in theesophagus 16 using the process described above, which temporally sealsthe esophagus 16 to deliver air to the respiratory passage 18.

In either case, the device 100 is configured to begin assistedventilation by delivering a bolus of air 40 at a pre-determined rate.The device 100 is configured to measure a condition of a thoracic cavityto determine a change in the thoracic cavity, either through pressurewithin the thoracic cavity as denoted by PT or a force F applied to thethoracic cavity via chest compressions. In the latter case, the force Fapplied to the chest causes movement of tissue (such as the trachea orother tissue) that can be determined by a force detecting component 190as discussed above. The detection of a chance in the thoracic cavity bymeasuring a fluid characteristic such as a change in pressure PT istypically measured within a body passageway (such as the trachea 18 oresophagus 16). Such measurements can include measuring flow rate of air,volume, pressure, etc.

In one variation, the initial or pre-determine rate comprises 100ventilations per minute (i.e., a bolus of air is delivered 100 times perminute). However, any rate of delivery is within the scope of thisdisclosure. Upon detecting a change in the condition of the thoraciccavity, typically due to chest compressions, the device 100 will adjustthe timing and/or rate of air delivery to achieve an optimum result. Forexample, the system can deliver a bolus of air upon detecting the chestcompression (either by the force measurement or via the fluid sensormeasurement). In such a case, the bolus of air increases pressure in thethoracic cavity to serve as an internal chest compression whichcompresses the heart and lungs from within causing increased blood flow.

In variations of the device, the system monitors for a change in acondition of the thoracic cavity on a continuous basis, or on a delay.In either case, the system can be configured to not respond to a changein the pressure of the thoracic cavity driven by the delivery of thebolus of air. For example, the system can ignore readings during andimmediately after the delivery of the bolus of air.

The process of adjusting the delivery of a bolus of air (either bytiming and/or rate) in response to a particular phase of the chestcompression is intended for use during CPR. However, the assistedventilation can be accomplished whether using a mechanical compressionsystem or a caregiver performing manual chest compressions.

The alteration of the timing and/or rate is intended to provide a bolusof air with each or a specific number of compression and at a specificphase of the compression of the patient's chest. As noted herein, theventilations are timed in a way that both increased the efficiency ofthe chest compression by increasing intrathorasic pressure during thedown stroke of the chest compression, which would increase the pressureon the heart thus increasing blood flow. During the up stroke of thecompression the a portion of the ventilation could still be given toallow new air enter the alveoli while allowing a portion of the upstroke of the compression to create a negative intrathorasic pressuredrawing blood back into the heart and air into the alveoli. Thistechnique also prevents a rescuer from having to pause compressions inorder give ventilations, which decreases blood flow and decreases oddsof patient's survival.

When using the devices described herein, regardless of whether thedevice is positioned in the trachea or esophagus, the airway is alwaysopened to the outside environment which greatly reduces, if noteliminates, the chance of barotrauma.

The data generated by the devices described herein regarding theefficiency of the compression regarding depth, rate, recoil time can beanalyzed and presented via feedback to the caregiver in order tomaximize the efficiency of the compressions. All of this information andbe used to increase the efficiency of the compressions and thereforeincrease blood flow of the patient and increasing patients chance ofsurvival. If using a mechanical compression system the cycle phase couldbe directly linked to the device 100.

Furthermore, the system can be configured to return to a pre-determinerate of providing the bolus of air, if at any time chest compressionstop/pause. In such a case, the system can monitor the amount of timeduring which a change in the thoracic cavity is not detected. If nochange is detected for a pre-set time, the control unit can reset therate of assisted ventilation to the initial rate or an alternate ratethat is not dependent upon chest compression. In addition, if thepatient's pulse resumes, the system can continue to provide assistedventilation at a pre-determined rate, volume, etc. Alternatively, thesystem can enter a manual mode where a caregiver can deliver assistedventilation upon demand (e.g., using the manual trigger button).Furthermore, the system can be configured to check for a patient's pulseand use identification of the pulse to adjust the rate of assistedventilation or cease assisted ventilation.

The manual trigger allows the caregiver to give a controlled ventilationon demand button may be beneficial once the patient has regained a pulseeliminating the need for external chest compression. As noted above, thedevice 100 can still continue isolation of the lungs by collapsing theesophagus with suction and/or direct air through the proper lumen intothe lungs but changes the ventilation to an air bolus given on demandgiven by the caregiver. The manual trigger allows the caregiver to startthe flow of air to the lungs. Release of the trigger stops the flow ofair to the lungs to allow the patient to exhale. Alternatively, a singleactuation of the trigger can give a preset amount of air that ventilatesthe patient.

The system described herein can also be used with conventional rescuedevices. For example, the ventilation system can be configured to workwith an active chest compression device so that ventilations and chestcompressions are timed to increase effectiveness of both the compressionand ventilation. The coupling can be mechanical and/or electrical. Theventilation system can also include carbon dioxide sampling so thatcarbon dioxide levels are outputted via a signal or gas stream to amonitor or other notification means as described herein.

FIGS. 11A and 11B illustrate a variation of a system for artificiallyventilating an individual using a source of oxygen, such as thosedescribed herein. In the illustrated example, the device 100 is notshown for purposes of clarity in illustration how the control system 150can be used as a stand-alone unit having electrical control systemshaving firmware can be controlled through the system interface 152, orcan be integrated or controlled with an external device (e.g., a cardiacmonitor, monitor/defibrillator, or other critical care device). Asshown, the control unit 150 can be mounted on the external device 162and coupled to a source of oxygen 160. As shown in FIG. 11B, oncecoupled to the external device 162, the control unit 150 can be operatedusing the on-board controls 152 or can be controlled via the externaldevice 162 via a wireless or wired connection. In such a case and asshown in FIG. 11C, one or more of the on-board controls 152 of thecontrol unit 150 can be displayed on the control/display 164 of theexternal device 162. The variation shown in FIG. 11C illustratescontrols for operating the device 100 in a CPR mode, on-demand mode, orsuction mode. However, any number of items can be displayed on thecontrol/display 164 and/or on the on-board controls 152.

For example, the device 100 can display information relating to thephase, rate, efficiency, depth, ratios of chest compression during CPR.Additionally, the device can display information for giving an operatorreal time feed-back on the efficiency of the assisted compressions viaaudible or visual feedback as well as information on whether to increaseor decrease the speed of manual compressions, or whether to resume chestcompressions if pulses are lost or the caregiver stops chest compressionfor too long.

The device 100 can also be configured with a rechargeable power supplythat can be charged when coupled to an external device 162, or where theconnection allows for charging the device 100 via a typical AC powersource. In most cases, the control unit 150 will carry a power supplycapable of powering the device for a sufficient period of operation anda sufficient stand-by period.

FIG. 12 illustrates an additional improvement to increasing theportability of the control unit 150. In this configuration, the controlunit 150 relies upon the source of oxygen 160 to provide ventilation tothe individual as well as to produce the vacuum described above.Accordingly, to extend the source of the oxygen, the device can employone or more vacuum valves 200, 202 that produce a vacuum as a result ofthe pressurized flow of oxygen where one vacuum valve operates at a highflow to generate suction. Once a vacuum is established for a certainperiod of time, the system can switch to a low flow vacuum valve 202that generates high vacuum with low flow. Such a configuration extendsthe life of the oxygen supply.

In another variation, the devices described herein can be used todetermine ventilation parameters using tubing that accommodatesdifferent sizes. For example, having a variety of working ends ofdifferent sizes that were coordinated with a Broslow tape for pediatricapplications. This way a caregiver could simple select the size airwaythe Broslow tape recommended and attach to the ventilator. The caregiverwould not have to adjust the ventilation parameters because either theauthentication process would signal to the ventilator the approximatesize of the patient based on the airway selected. Alternatively, theairway itself would reduce the volume, pressure, suction pressure thatthe patient received. An example of this method would be a narrowing ofthe ventilation tubing that restricted flow so the volume ventilatedover a period of time was less. Another example would be an exhaustvalve the dumped excess ventilation volume into the atmosphere, reducingboth the volume and pressure for ventilating the patient.

Method for being able to determine the phase, rate, efficiency, depth,ratios of chest compression during CPR by detecting the bending of atube placed in the patient's mouth, esophagus via various methods.Including but not limited to, strain gauges on tube, fiber optics, airmovement sensors. A method for timing ventilations at a certain phase ofthe compression to maximize the efficiency of CPR while allowingadequate gas exchange. Using the technology mentioned in the methodabove attached the ventilator. A method for continuing ventilationsafter compressions are stopped or paused. A method for giving operatorreal time feed back on the efficiency of rescuers compressions viaaudible or visual feedback.

Some of the features of the systems described above include: a methodfor placing electrodes on the tube and pacing the heart via tube placedin the mouth, esophagus or trachea; a method for defibrillating theheart through electrodes placed on a tube in the mouth, trachea oresophagus of a patient; and a method for determining if the patient hasa pulse through a tube in the patients mouth, trachea or esophagus.

FIGS. 19-28 illustrate an example of the circuitry for sensing thephase, rate, depth and effectiveness of a chest compression with aresistor placed on the tube of an airway placed in the patient's mouth,trachea or esophagus. The information can be relayed to the rescuer orused to signal a valve to time a ventilation. This is only one exampleof how to implement the invention described above by no way are welimiting other methods mentioned above.

The preceding merely illustrates the principles of the invention. Itwill be appreciated that those skilled in the art will be able to devisevarious arrangements which, although not explicitly described or shownherein, embody the principles of the invention and are included withinits spirit and scope. Furthermore, all examples and conditional languagerecited herein are principally intended to aid the reader inunderstanding the principles of the invention and the conceptscontributed by the inventors to furthering the art, and are to beconstrued as being without limitation to such specifically recitedexamples and conditions. Moreover, all statements herein recitingprinciples, aspects, and embodiments of the invention as well asspecific examples thereof, are intended to encompass both structural andfunctional equivalents thereof. Additionally, it is intended that suchequivalents include both currently known equivalents and equivalentsdeveloped in the future, i.e., any elements developed that perform thesame function, regardless of structure. The scope of the presentinvention, therefore, is not intended to be limited to the exemplaryembodiments shown and described herein. Rather, the scope and spirit ofpresent invention is embodied by the appended claims.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “astring” may include a plurality of such strings and reference to “thetubular member” includes reference to one or more tubular members andequivalents thereof known to those skilled in the art, and so forth.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specificallyexcluded limit in the stated range. Where the stated range includes oneor both of the limits, ranges excluding either or both of those includedlimits are also included in the invention.

All publications mentioned herein are incorporated herein by referenceto disclose and describe the methods and/or materials in connection withwhich the publications are cited. The publications discussed herein areprovided solely for their disclosure prior to the filing date of thepresent application. Nothing herein is to be construed as an admissionthat the present invention is not entitled to antedate such publicationby virtue of prior invention. Further, the dates of publication providedmay be different from the actual publication dates which may need to beindependently confirmed.

We claim:
 1. A device for assisting in ventilation of an individual, thedevice comprising: a tubular member having at least a first lumen and asecond lumen, where the first lumen is fluidly coupled to a firstopening located distally relative to a medial opening, where the medialopening is fluidly coupled to the second lumen, where the first openingand medial opening are each fluidly isolated within the tubular member;a sensor configured to measure a condition of a body passageway todetermine a change in a thoracic cavity of the individual; a controlunit having a suction source and a gas supply, the control unit having avalve configured to fluidly couple the gas supply to either the firstlumen or to the second lumen; the control unit also capable of drawingsuction from the suction source through the first lumen and the firstopening, where the control system is configured to monitor the firstlumen for a vacuum to indicate collapse of the body passageway andformation of a seal at the first opening wherein the control unitmaintains suction while delivering a gas from the gas supply at adelivery rate through the second lumen and the medial opening; where thecontrol system is configured to deliver the gas at the delivery ratethrough the first lumen and first opening upon failing to detectformation of the seal at the first opening; and where the control unitis configured to alter the delivery rate based upon a reading of thepressure sensor.
 2. The device of claim 1, where sensor comprises atleast one strain gauge configured to measure the condition of the bodylumen to determine the change in a thoracic cavity through deformationof the tubular member.
 3. The device of claim 1, where the sensorcomprises at least one pressure sensor configured to measure thecondition of the body lumen to determine the change in a fluid parameterof the thoracic cavity.
 4. The device of claim 3, where the sensor islocated on or in the tubular member.
 5. The device of claim 3, furthercomprising a sensor lumen extending in or with the tubular member, themeasuring lumen in fluid communication with the sensor.
 6. The device ofclaim 3, where the sensor comprises an air pressure sensor configured todetect movement of air within the body lumen resulting from compressionand decompression of a chest of the patient.
 7. The device of claim 1,where the control unit is configured to generate a feedback signal basedon measuring the condition of the thoracic cavity.
 8. The device ofclaim 7, where the feedback signal comprises information regardingcompression of the thoracic cavity selected from group consisting of aphase of compression, a rate of compression, an efficiency ofcompression, a depth of compression, and a timing of compression.
 9. Thedevice of claim 7, where the control unit is configured to be coupled toa second medical device.
 10. The device of claim 7, where the controlunit is configured to be coupled to a display device.
 11. The device ofclaim 1, where the control unit is configured to continue to monitor thecondition of the body lumen cavity to determine the change in thethoracic cavity after altering the first rate and to revert the firstrate upon failure to detect the change in the body lumen.
 12. The deviceof claim 1, where the control unit comprises a manual mode which isconfigured to allow a user to manually ventilate the patient through theventilation path.
 13. The device of claim 1, where the control unitcomprises a manual mode which is configured to allow a user to manuallyventilate the patient through the ventilation path.
 14. The device ofclaim 1, further comprising a mask slidably positioned along the tubularmember.
 15. The device of claim 14, where the mask comprises an edgeconfigured to form a seal against a respiratory opening of theindividual to isolate the respiratory opening from an externalatmosphere.
 16. The device of claim 15, further comprising a manualventilation trigger, and where the mask forms a seal on actuation of themanual ventilation trigger.
 17. The device of claim 1, furthercomprising at least one electrode located on the tubular member, wherethe at least one electrode is configured to apply stimulation current tothe individual.
 18. The device of claim 1, further comprising a pulsemonitoring sensor located on the tubular member, the pulse monitoringsensor configured to monitoring a pulse of the individual and transmitsa pulse signal to the control unit.
 19. The device of claim 1, furthercomprising a capnography lumen extending through the tubular memberhaving a first end terminating at an opening in the tubing and a secondend coupleable to a capnograph device.
 20. The device of claim 1, wherethe control unit is portable.
 21. The device of claim 1, where thecontrol unit includes one or more on-board controls.